关于新机械指令2006/42/EC的一些问题（FAQ)

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1. Question:--关于过渡期
/ {  i: I# N# G$ Q: c/ iIs there a transition period for application of Directive 2006/42/EC?
& j% g, m" p% T% v- f0 v1 o4 _- wAnswer :
% o2 o8 N& k- e: k" J/ |- Y& C" PIn general, there is no transition period, in the sense of a period during which both the current
# w" L2 _/ J7 r; q2 O1 Q2 H5 EMachinery Directive and the new Machinery Directive are applicable (with one exception: there is a
transition period until 29th June 2011 for the particular case of portable cartridge-operated fixing and
other impact machinery).
However there is a period of adaptation, since the provisions of the Directive 2006/42/EC become
/ B1 F  v, C7 U, Z9 wapplicable on 29th December 2009. During this period, all of the stakeholders concerned will be able to
take the necessary steps to ensure a smooth transition from the current Directive to the new Directive.
  `! N4 b/ }- X2 |& g2. Question:--关于是否使用新旧指令
6 r, f5 o( p3 c5 p! l, b# Q& UCan manufacturers anticipate application of the new Machinery Directive?的应用
! m- S' I' ~% w" N( K7 rAnswer:
Yes and no. Manufacturers can and should anticipate application of Directive 2006/42/EC from a
practical and technical point of view, however, from a formal, legal point of view, the Directive cannot
2 w4 |3 ?' ^' sbe applied before 29th December 2009:
- From the practical and technical point of view, manufacturers are encouraged to review their
products without delay and adapt them as necessary to take account of the requirements of the
3 I2 b% A! N2 Q) P+ ]) D. Pnew Directive. While machinery placed on the market before 29th December 2009 must
2 Z. z3 b/ C, Z" m/ T4 a: q& Pcontinue to comply with Directive 98/37/EC, it can be assumed that a product that complies
; z( _; C% ~( w7 `with the essential requirements of the new Machinery Directive continues to comply with the
current Directive.
6 M; X' P+ L& ~& v. Q  |6 `- From the formal, legal point of view, machinery can only be placed on the market with
% m4 [8 q6 t& }9 r: A! Nreference to Directive 2006/42/EC as from 29th December 2009.
! o  j$ u# g% a2 {# x% ?" F/ a- F3. Question:---满足新指令宣告
When shall a manufacturer establish an EC Declaration of conformity according to Directive
) E# G# }) a  _" X2006/42/EC?
+ ?* _5 W. h) l5 o  y: v- _, tAnswer:
A manufacturer shall establish an EC Declaration of conformity according to Directive 2006/42/EC
for products first placed on the market as from 29th December 2009.
In cases where the manufacturer cannot be certain on what date individual products will be first placed
on the market, providing the products concerned comply with both the current and the new Directives,
he may establish an EC Declaration of conformity referring to both Directive 98/37/EC and Directive
2006/42/EC. The reference to Directive 98/37/EC should be removed from the EC Declaration of
conformity after the 29th December 2009.
4. Question:---关于旧指令的协调标准新指令是否适用
4 K( k+ S# @' e# }! o6 RCan the current harmonised standards be used to comply with Directive 2006/42/EC?
Answer:
# @( n: {! H9 M2 A7 b& YSince there have been some modifications to the essential health and safety requirements set out in
Annex I, it cannot be assumed that the current harmonised standards comply fully with Directive
0 L) B. j. w  B/ f- S' X2006/42/EC.
The European Commission is issuing a mandate to CEN and Cenelec to develop the necessary new
standards and ensure that the current standards are checked against Directive 2006/42/EC and adapted
. N- ?2 y& U7 q& x! Aas necessary. Furthermore, all harmonised standards must include a reference to the new Directive.
The Commission intends to publish a list of harmonised standards supporting Directive 2006/42/EC
* k8 A1 x  Z4 y& p+ l- ~* O+ v. cbefore the Directive becomes applicable.
4 Y8 D5 n, G* j5. Question:--关于附录IV产品，制造商何时可以使用全新的质量保证程序
0 n( R' F( w* Z. {. Z: ]& DWhen will manufacturers be able to use the new full quality assurance procedure for Annex IV
  X3 r/ L* u# F& s* B, tmachinery?
# O' N. w8 M9 _5 K6 kAnswer:
The Member States will first have to assess, appoint and notify Notified Bodies for the new full
" l2 R, m$ ]1 }! ]$ cquality assurance procedure set out in Annex X of the new Directive. This can be done as soon as
+ V* Y2 k, p( e* oDirective 2006/42/EC has been transposed into national law.
# R; y2 X- n$ }4 ]) s9 CAs soon as Bodies have been notified for this procedure, they will be able to carry out the necessary
audits and inspections and issue approvals of manufacturers’ full quality assurance systems. However,
products cannot be placed on the market on the basis of such approvals until Directive 2006/42/EC
becomes applicable on 29th December 2009.
' a% u  A3 P# ~4 k$ P6. Question:--关于现有的NB能否做新指令的型式认证
; \' O( l# u! i) UWill the existing Notified Bodies be able to carry out EC type-examinations according to Directive
2006/42/EC?
Answer:
Bodies that are notified to carry out EC type-examinations under Directive 98/37/EC will be able to
) Y( i2 m5 ?. n- Z: {$ v/ `- W0 Lcontinue to carry out EC type-examinations under Directive 2006/42/EC, providing their notification
covers the product categories concerned.
1 y! }8 Q+ S* G: ^For product categories included in Annex IV of Directive 2006/42/EC that are not listed in Annex IV
# y2 g1 z+ [( O( z' c* ?) iof Directive 98/37/EC, the Member States will have to notify new Bodies or extend the scope of the
notification of existing ones.
( U3 @3 k, s& W2 H
7. Question:--关于按旧指令做的型式认证是否适用于新指令
Will EC type-examination certificates established according to Directive 98/37/EC remain valid for
7 u& n4 f4 W/ J2 X( a# x- NDirective 2006/42/EC?
Answer:
/ C% u; C" g( c$ QSince there have been some modifications to the essential health and safety requirements set out in
Annex I, it cannot be assumed that EC type-examination certificates issued according to Directive
& t' x& H3 u4 d- p9 |2 R* x$ [98/37/EC remain valid for Directive 2006/42/EC. Furthermore, such certificates must be updated to
refer to Directive 2006/42/EC..
Notified Bodies will thus have to review existing EC type-examination certificates to ensure that they
remain valid in light of the requirements of the new Directive and update them to refer to Directive
( |# R( r0 G: I) `5 \2006/42/EC. Manufacturers are encouraged to request this review without delay in order to avoid a
bottleneck in the months preceding December 2009.
Since Directive 2006/42/EC requires EC type-examination certificates to be reviewed every 5 years
(see Annex IX, section 9.3), the 5-year period for existing certificates can be counted from the date on
7 L3 N  F$ Z; R/ y7 pwhich they have been updated according to Directive 2006/42/EC.
4 K/ p& Y$ a6 s. |/ d! O# q8. Question:
What will happen to products certified according to one of the procedures set out in Article 8 (2) (c)
of Directive 98/37/EC (Receipt of techncial file or Certificate of adequacy to harmonised
) e: k2 F9 A9 H6 Istandards)?
Answer:
The procedures set out in Article 8 (2) (c) of Directive 98/37/EC will no longer exist under Directive
2006/42/EC. As from 29th December 2009, manufacturers of products placed on the market on the
basis of these procedures will therefore have to apply one of the procedures set out in Article 12 (3)
9 V0 X% a* H2 Gand (4) of Directive 2006/42/EC.
' t8 O6 I  f* w9 AFor products manufactured in accordance with harmonised standards that cover all the relevant health
and safety requirements, the manufacturer will be able to certify the conformity of the product himself
according to the procedure set out in Article 12 (3) (a) of the Directive.

2 M0 k  w4 B  J( u' s0 a- H7 `, y
0 n( h2 {# \2 W/ Q4 G9 \http://ec.europa.eu/enterprise/mechan_equipment/machinery/faq2006-42-ec.pdf
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